USA – Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products

Branded and generic drugs industry groups are sparring over the US Food and Drug Administration’s (FDA) approach to regulating biosimilar and interchangeable insulin products following a public meeting on the matter last month.
In March 2020, FDA will begin transitioning certain biological products – such as insulin, insulin analogs and human growth hormone – that were initially approved under new drug applications (NDAs) to be deemed to be licensed under section 351 of the Public Health Service Act (PHS Act).

After the transition, the newly deemed insulin products can be used as reference products for biosimilar or interchangeable insulin products. In December, FDA issued two draft and two final guidances, as well as a proposed rule, aimed at clarifying its expectations for biosimilars and deemed to be licensed products.

In comments submitted to the public docket for the hearing, the Association for Accessible Medicines (AAM) says it believes FDA should better pave the way for interchangeable insulin products…